The world’s first nucleic acid CRDMO offering continuous RNA manufacturing services
- From early discovery up to cGMP manufacturing of mRNA & saRNA therapeutics
- We offer the world’s first continuous mRNA manufacturing platform
Discovery
Starting from a known antigen, we can provide support for the design and production of mRNA-based therapeutics.
Exothera’s discovery services for RNA therapy developers involved in early-stage discovery (antigen definition) provides access to RNA expertise, process knowhow and production systems at each stage of the discovery workflow, from RNA design, and manufacture up to in vitro screening for potency and manufacturability demonstration, all from a single provider.
- EAntigen definition
- EConstruct design
- EConstruct screening
- EFormulation screening
Exoscan nucleic acids Process Analysis
For companies in preclinical and Phase I we review your current RNA production method and compare it to our exoREADY manufacturing process. Based on this, we prepare a detailed report demonstrating the quality, performance, speed, and lower CoGs that can be achieved using the exoREADY process, aligned with your specifications and expectations.
- EProduction method review and data analysis
- ERisk and gap identification
- ETechnology comparison
- ECost modelling
Non-GMP manufacturing
We produce mRNA product for preclinical testing.
Our ExoREADY process for preclinical RNA production can achieve cost-effective and high-quality RNA production quickly to accelerate your therapy development.
- EmRNA production & formulation of selected candidates
- EConstruct specific analytical method development
- EAnalytical characterization of purified and formulated candidates thanks to our extensive analytical assays offer.
GMP Manufacturing
At Exothera, we have one of the largest GMP commercial-scale factory in Europe covering 8,600 m²/90.000 sqf. This allows us to produce GMP products for clinical & commercial needs using our ExoREADY process to suit your mRNA therapeutic needs.
We have the production capacity and expertise to deliver complex mRNA projects quickly and economically.
- EManufacture of HQ Grade DNA for GMP purposes (starting material)
- EManufacturing of RNA product: up to 5g purified RNA/day (up to 500k doses per day)
- ECMC support
- EGMP manufacturing, testing and release services
- EFormulation and encapsulation in LNP
- EFill & Finish
- EStorage
- EStability studies on Drug Substance and Drug Product
Analytics
Our analytical capabilities cover the whole spectrum from DNA, RNA and LNPs. We support analytical development from discovery to bridging capabilities for preclinical and clinical processes, up to quality control during GMP manufacturing.
- EDevelopment of new analytical methods
- ERoutine analysis of R&D samples based on our standard analytical qualified methods catalog
- EAnalysis of GMP samples based on our QC’s validated method catalog
Discovery
Starting from a known antigen, we can provide support for the design and production of mRNA-based therapeutics.
Exothera’s discovery services for RNA therapy developers involved in early-stage discovery (antigen definition) provides access to RNA expertise, process knowhow and production systems at each stage of the discovery workflow, from RNA design, and manufacture up to in vitro screening for potency and manufacturability demonstration, all from a single provider.
- EAntigen definition
- EConstruct design
- EConstruct screening
- EFormulation screening
Exoscan nucleic acids Process Analysis
For companies in preclinical and Phase I we review your current RNA production method and compare it to our exoREADY manufacturing process. Based on this, we prepare a detailed report demonstrating the quality, performance, speed, and lower CoGs that can be achieved using the exoREADY process, aligned with your specifications and expectations.
- EProduction method review and data analysis
- ERisk and gap identification
- ETechnology comparison
- ECost modelling
Non-GMP manufacturing
We produce mRNA product for preclinical testing.
Our ExoREADY process for preclinical RNA production can achieve cost-effective and high-quality RNA production quickly to accelerate your therapy development.
- EmRNA production & formulation of selected candidates
- EConstruct specific analytical method development
- EAnalytical characterization of purified and formulated candidates thanks to our extensive analytical assays offer.
GMP Manufacturing
At Exothera, we have one of the largest GMP commercial-scale factory in Europe covering 8,600 m²/90.000 sqf. This allows us to produce GMP products for clinical & commercial needs using our ExoREADY process to suit your mRNA therapeutic needs.
We have the production capacity and expertise to deliver complex mRNA projects quickly and economically.
- EManufacture of HQ Grade DNA for GMP purposes (starting material)
- EManufacturing of RNA product: up to 5g purified RNA/day (up to 500k doses per day)
- ECMC support
- EGMP manufacturing, testing and release services
- EFormulation and encapsulation in LNP
- EFill & Finish
- EStorage
- EStability studies on Drug Substance and Drug Product
Analytics
Our analytical capabilities cover the whole spectrum from DNA, RNA and LNPs. We support analytical development from discovery to bridging capabilities for preclinical and clinical processes, up to quality control during GMP manufacturing.
- EDevelopment of new analytical methods
- ERoutine analysis of R&D samples based on our standard analytical qualified methods catalog
- EAnalysis of GMP samples based on our QC’s validated method catalog